The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease (CLIMB)
|Chronic Obstructive Pulmonary Disease||Drug: Chlorhexidine Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive|
- Change in sputum bacteria [ Time Frame: Baseline, 8 weeks ]Microbiome DNA
- Symptoms of COPD [ Time Frame: Baseline, 8 weeks ]Questionnaire
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Oral RinseOther: Placebo
Placebo Comparator: Placebo
Oral RinseOther: Placebo
Our hypothesis is that 8 weeks of chlorhexidine oral rinse will decrease microbiota biomass compared to baseline and those on placebo. Furthermore, we hypothesize that chlorhexidine treatment will: i) decrease lung and oral microbiota diversity; ii) alter microbiota taxonomic composition in the lung and oral cavity; iii) decrease systemic inflammation as measured by blood high sensitivity C-reactive protein (hsCRP), fibrinogen and leukocyte count; and iv) demonstrate a trend towards improvement in respiratory health status as measured by the Breathlessness, Cough, and Sputum Scale (BCSS)[1, 2] and St. George's Respiratory Questionnaire (SGRQ).
Subaim 1: Determine if chlorhexidine alters the lung and oral rinse microbiota diversity and taxonomic composition. Our hypothesis is that chlorhexidine oral rinse will decrease the diversity (Shannon and inverse Simpson diversity indices) and taxonomic composition of both oral and lung microbiota compared to those on placebo as determined by next-generation sequencing of the bacterial 16S rRNA gene.
Subaim 2: Determine the impact of chlorhexidine on systemic inflammation. Our hypothesis is that the decrease in lung microbiota biomass is associated with a decrease in systemic inflammation as measured by blood hsCRP, fibrinogen, and leukocyte count.
Subaim 3: Determine if respiratory symptoms associate with the lung microbiota biomass. Our hypothesis is that chlorhexidine will demonstrate improved respiratory health status as measured by the BCSS and SGRQ.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02252588
|Contact: Sue Johnson, BA||612-629-7492||Susan.Johnson4@va.gov|
|United States, Minnesota|
|VA Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Chris Wendt, MD||VA Office of Research and Development|